The MHRA announced in January 2014 that the pharmaceutical industry is expected to review data integrity within the frame of self inspections.
Now, a Guideline of the MHRA on data integrity was published in January 2015. According to the MHRA, data integrity in a pharmaceutical quality management system is fundamental to ensure that the medicinal products are of the quality required.
The Guideline describes MHRA's expectations for data in the GMP environment of pharmaceutical companies. These requirements should complete the existing regulations from the EU GMP and Eurdralex Volume 4.
The MHRA expects a so-called "data governance system". No forensic approach to data checking is expected but a system should be developed and run which gives an acceptable state of control based on the data integrity risk. This system should be fully documented and have a "supporting rationale"!
The requirements apply to both manual (paper) and electronic data. "Manufacturers and analytical laboratories should be aware that reverting from automated / computerised to manual / paper-based systems will not in itself remove the need for data integrity controls." A marketing authorisation holder is expected to implement scientific and technical progress.
For further information please see the MHRA's complete document (15 pages) GMP Data Integrity Definitions and Guidance for Industry January 2015.
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